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UDI and the impact on medical devices (Part 2 – Labeling)

The Food & Drug Administration (FDA) is currently establishing an unique device identification system. In part 1 of this blog we explained the fundamentals of the UDI system, its rules and special features.

In this part, we will give you label examples and provide information on Direct Permanent Marking DPM. These are typically 2D Matrix Symbols permanently marked by special methods. As a conclusion, we will talk about FDA’s final rule – and its five basic requirements.

2. Label

This chapter provides some label examples.

Fictitious label explained

Real world example with 1D bar code

Real world example with small labels

3. Direct permanent marking DPM

Direct part marks are typically 2D Data Matrix symbols permanently marked by methods such as dot peen or laser/chemical etch onto substrates including metal, plastic, rubber or glass. These marking methods often result in low contrast visibility of the symbol or inconsistent imprints that can be challenging to decode through traditional imaging technology.

To write a DPM, a specialized (laser) device has to complement the production line. A reader is a camera based system including an illumination stage. Readers are available as handheld devices.

4. Conclusion

FDA’s final rule – the five basic requirements:

The label of each and every medical device must have a UDI.

Assign a globally unique, standardized identifier to devices.

Apply the identifier to the device’s label in both plain text (human readable interpretation/HRI) and in an appropriate form of Automatic Identification and Data Capture (AIDC) technology (e.g. linear or two-dimensional barcodes).

Directly mark (that is, put the UDI on the device itself) those devices that are intended to be reused and reprocessed.

Provide identifying information (metadata) to FDA’s UDI database so that other people can use and draw meaning
from the identifier.

UDI and Zühlke?

Do you have any project related to UDI? Marking, reading or the required software application? We are looking forward to your feedback to this blog.

Thanks to my colleague Dr. Rainer Schmidt from Zühlke for his UDI know-how.